A Phase 2 interventional study of Dasatinib and Ropeginterferon alfa-2b (P1101) in Chronic Myeloid Leukemia, sponsored by M.D. Anderson Cancer Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by M.D. Anderson Cancer Center · Phase 2, Interventional, and Treatment
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Among 45 studies testing dasatinib in Leukemia, Myelogenous, Chronic, BCR-ABL Positive — 4 open to participants now, 6 under way, none of them phase 3. Dasatinib · Leukemia, Myelogenous, Chronic, BCR-ABL Positive.
Among the 45 studies testing dasatinib in Leukemia, Myelogenous, Chronic, BCR-ABL Positive, this one is the 32nd largest by planned enrollment of the 43 interventional ones that give a count, is the only one that started in 2026, is one of 28 in phase 2, and was the 44th registered.
894 studies on the registry are indexed under Leukemia, Myelogenous, Chronic, BCR-ABL Positive; 109 are open to participants now.
Browse Leukemia, Myelogenous, Chronic, BCR-ABL Positive studies →4 of the 45 studies testing dasatinib in Leukemia, Myelogenous, Chronic, BCR-ABL Positive are open now, in 12 countries. Recruiting first, the newest first:
Novartis Pharmaceuticals · Sites in United States, Argentina, Austria and 26 more countries
Ages 7–100
Medical College of Wisconsin · Sites in United States
Ages 18+
Prof. Dr. med. Andreas Hochhaus · Sites in Germany
Ages 18+
By country, each count listing its studies:
Dasatinib: first FDA approval 2006 (SPRYCEL), first EMA approval 2024. What it is approved for, and how studies give it, is on its page →
Of the 79 Leukemia, Myelogenous, Chronic, BCR-ABL Positive studies recruiting now, 48 (61%) set no upper age limit and 20 (25%) stop at 75 or younger; 20 take children under 18; 7 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
45 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 10 · Phase 2 33 · Phase 3 4 · Phase 4 3
First in 2001; this study’s year is marked. 1 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 40 is close to the median of 44 across 681 interventional studies indexed under Leukemia, Myelogenous, Chronic, BCR-ABL Positive.
Median enrollment 56 across the 43 interventional studies. Of the 32 that completed or were terminated, 14 (44%) have results posted.
This tab as a report to print or save as PDF → With an account.
16 of 45 have an industry lead sponsor. The 10 most frequent:
M.D. Anderson Cancer Center is the lead sponsor of 3,047 studies on the registry; 578 are open to participants now.
Of its 612 completed or terminated interventional studies of FDA-regulated products, 409 (67%) have results posted.
75 studies in Leukemia, Myelogenous, Chronic, BCR-ABL Positive by M.D. Anderson Cancer Center: 8 open now, 11 under way, none of them phase 3. Of 59 finished, 35 (59%) have results posted.
Among the 75 studies in Leukemia, Myelogenous, Chronic, BCR-ABL Positive by M.D. Anderson Cancer Center, this one is the 31st largest by planned enrollment of the 73 interventional ones that give a count, is the only one that started in 2026, is one of 42 in phase 2, reaches primary completion later than 5 of the 10 other live ones, and was the 75th registered.
M.D. Anderson Cancer Center’s Leukemia, Myelogenous, Chronic, BCR-ABL Positive studies by the year they started, since 1994.
None of the studies under way reaches primary completion within a year.
Among the 45 studies testing dasatinib in Leukemia, Myelogenous, Chronic, BCR-ABL Positive, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among M.D. Anderson Cancer Center’s 75 in Leukemia, Myelogenous, Chronic, BCR-ABL Positive:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
The goal of this clinical research study is to find out if treatment with a combination of dasatinib plus ropeginterferon can help to control CML-CP. The safety of this combination will also be studied.
Primary Objective:
To assess the rate of molecular response 4.5 (4.5 log-reduction of BCR::ABL1 transcripts or level ≤ 0.0032% IS) by 12 months of therapy
Secondary Objectives:
To assess the rate of complete cytogenetic response (BCR::ABL1 transcripts ≤ 1% IS) by 12 months of therapy
To assess the rate of major molecular response (BCR::ABL1 transcripts ≤ 0.1% IS) by 12 months of therapy
To estimate the proportion of patients achieving MR4.5 at 6, 18, 24, and 36 months of therapy
To estimate the rate of sustained deep molecular response (DMR; BCR::ABL1 transcripts ≤ 0.01% IS) for 2 years and longer
To evaluate the safety of the combination
To assess event-free survival and overall survival for 10 years after the last patient is enrolled
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Adult patients age ≥18 years.
Patients must have a diagnosis of Ph-positive or BCR::ABL1 positive CML in chronic phase.
Patients who received prior hydroxyurea, 1 to 2 doses of cytarabine, and/or an FDA approved TKI for \<30 days are eligible.
Patients with additional chromosomal abnormalities at diagnosis (early disease) and no other criteria for accelerated phase will be eligible for this study.
performance status ≤2.
Patients must have adequate end organ function, defined as the following: total
≤1.5x (unless secondary to Gilbert's disease, in which case should be ≤2.5x ULN), or SGOT ≤3x ULN, ≥30mL/min calculated using modified Cockcroft-Gault.
Ability to understand and the willingness to sign a written document.
Dasatinib is known to be teratogenic. For this reason, women of and men must agree to use adequate (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114). This includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following:
Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject/Partner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
For patients with evidence of chronic virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
Patients with a history of virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
(HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
Patients with a prior or concurrent whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the regimen are eligible for this trial.
Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the Functional Classification. To be eligible for this trial, patients should be class II or better.
Exclusion Criteria:
Patients who have received more than 30 days of prior FDA approved TKI or more than 2 doses of cytarabine.
Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities > Grade 1) with the exception of alopecia.
Patients who are receiving any other agents.
History of allergic reactions attributed to compounds of similar chemical or biologic composition to dasatinib, ropeginterferon, or other agents used in study.
cardiac class III-IV heart disease.
Active disease at screening.
History or presence of depression
Patients with active, uncontrolled psychiatric disorders including psychosis, major depression, and bipolar disorders.
Patients with cognitive impairment or psychiatric illness/social situations that would limit compliance with study requirements.
Evidence of other clinically significant uncontrolled condition(s) including, but not limited to:
Any or to dasatinib or IFN-α and/or its
Patients in accelerated (except as noted in inclusion criteria 4.1) or blast phase are excluded.
Pregnant women are excluded from this study because dasatinib is an agent with potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with dasatinib, breastfeeding should be discontinued if the mother is treated with dasatinib. These potential risks may also apply to other agents used in this study.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive treatment on an outpatient basis.
Drug: Dasatinib · Drug: Ropeginterferon alfa-2b (P1101)
Given orally daily for 3 cycles
Also known as: Sprycel
Given subcutaneous through injection
Safety and Adverse Events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Time frame: Through study completion; an average of 1 year
Started Jul 2026 (actual). Primary completion is estimated for Nov 2029, 39 months after the start.
Of 101 non-industry phase 2 interventional studies under Leukemia, Myelogenous, Chronic, BCR-ABL Positive, half reached primary completion within 75 months of starting (the median), counting those still running; a quarter within 50 and three quarters within 130. This study's planned 39 months is below that.
Counting every sponsor, half of 126 studies reached it within 73 months; a quarter within 43 and three quarters within 124.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Dasatinib
Leukemia, Myelogenous, Chronic, BCR-ABL Positive →